Conference Program

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All Times EDT

Wednesday, September 21
Wed, Sep 21, 11:30 AM - 1:00 PM
Various Rooms
Roundtable Discussions

RL25: The Treatment and Handling of Missing Data in the Analysis of Real-World Data (303660)

*Gosford Aki Sawyerr, Syneos Health LLC 

Over the last decade, methods for the treatment and handling of missing data in RCTs have been implemented in regulatory settings following the issuance of the report released by National Research Council's Panel on Handling Missing Data in Clinical Trials. One strategy that has been employed is to fill in missing data in randomized controlled trials using RWD. In recent years, as a result of the FDA Cures Act, there has been an increase in the call for use of real-world data (RWD) to generate real world evidence (RWE) of product effectiveness to help support approval of new indications for drugs approved. Here also care needs to be exercised to address the problem of missing data, as electronic heath records may not have the data that are needed, and strenuous efforts will need to be exerted to extract fields that ultimately help reduce missingness in key endpoints. Our goal in this roundtable is to generate discussion on the treatment and handling of missing data in the analysis of RWD.